Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a randomized, placebo-controlled study

Abstract

TZP-101 appears to be safe, well-tolerated, and effective at acutely addressing several gastroparesis symptoms.

Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting - randomised clinical study subset data

“…18,19 Pharmacological doses of exogenous ghrelin have significant GI prokinetic effects in patients with both idiopathic and diabetic gastroparesis. TZP-101 accelerates gastric emptying in adults with diabetic gastroparesis, 20,21 and improves recovery of GI motility following bowel resection. 22 The pharmacokinetics of TZP-101 in patients with gastroparesis and healthy subjects are comparable and there is little accumulation of TZP-101 after multiple dosing.…”

“…23 Administration of TZP-101 is well tolerated and safety profiles are similar in placebo and TZP-101 treatment groups. [20][21][22] In a phase 2 trial in adult patients with type 1 or 2 diabetes, daily intravenous TZP-101 for 4 days demonstrated clinically and statistically significant improvements in several gastroparesis-related symptoms, including nausea and vomiting, postprandial fullness ⁄ early satiety and loss of appetite. 21 This study also showed that a single, daily dose of 80 lg ⁄ kg was the most effective dose.…”

“…[20][21][22] In a phase 2 trial in adult patients with type 1 or 2 diabetes, daily intravenous TZP-101 for 4 days demonstrated clinically and statistically significant improvements in several gastroparesis-related symptoms, including nausea and vomiting, postprandial fullness ⁄ early satiety and loss of appetite. 21 This study also showed that a single, daily dose of 80 lg ⁄ kg was the most effective dose. TZP-101 30-min IV infusion is in development for management of acutely presenting severe symptoms related to gastroparesis -typically severe vomiting and nausea that can result in the need for hospitalisation or emergency room care.…”

“…This report describes the subset analysis data for patients with severe nausea and vomiting enrolled in the phase 2 study described above. 21 …”

“…Detailed methods of study participants, randomisation and blinding procedures have been previously described. 21 Adult men and women (18-80 years) with type 1 or 2 diabetes mellitus and documented diagnosis of gastroparesis were electively admitted to a hospital and randomised to receive daily doses of intravenous TZP-101 or placebo for 4 days. Gastroparesis symptoms were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), which uses a six-point scale ranging from none (0) to very severe (5).…”